METOXIT CAM-BLANKS

K072569 · Metoxit AG · EIH · Oct 31, 2007 · Dental

Device Facts

• Record ID: K072569
• Device Name: METOXIT CAM-BLANKS
• Applicant: Metoxit AG
• Product Code: EIH · Dental
• Decision Date: Oct 31, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6660
• Device Class: Class 2

Intended Use

Metoxit blanks are indicated for use as a substructure for porcelain fused ceramic fixed dental restorations. All blanks are solely by or on the order of a dental professional. They are not for use by the general public or over-the-counter.

Device Story

Metoxit CAM-Blanks are yttrium-oxide stabilized tetragonal zirconium-oxide polycrystals (TZP/TZP-A) or aluminum oxide (Al-999) dental ceramics. Used by dental professionals to manufacture substructures for all-ceramic dental appliances. Blanks are machined via CAD/CAM or copying techniques, then sintered to full density and strength. Final restorations are veneered with porcelain. Used for single tooth restorations or bridgework in anterior and posterior regions. Benefits include high-strength ceramic framework for fixed dental restorations.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and material properties.

Technological Characteristics

Materials: Yttrium-oxide stabilized tetragonal zirconium-oxide polycrystals (TZP/TZP-A) and aluminum oxide (Al-999). Form factor: Ceramic blanks for CAD/CAM or copying machining. Processing: Machining followed by sintering to full density. Intended for use as dental substructures.

Indications for Use

Indicated for use as a substructure for porcelain fused ceramic fixed dental restorations, including single unit crowns and bridges (up to 2 pontics) in anterior and posterior regions. For use by dental professionals only; prescription use only.

Regulatory Classification

Identification

Porcelain powder for clinical use is a device consisting of a mixture of kaolin, felspar, quartz, or other substances intended for use in the production of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and veneers. The device is used in prosthetic dentistry by heating the powder mixture to a high temperature in an oven to produce a hard prosthesis with a glass-like finish.

Predicate Devices

• Cercon base (K013230, K051462)
• Cercon base colored (K051462)
• XAWEX G100 (K050903)
• Vita YZ cubes (K022996)
• Ivoclar ZIRCAD (K051705)
• Vita AL cubes (K052130)
• Sirona InCoris AL (K062506)
• DCS DC-Zirkon (K001815)

Submission Summary (Full Text)

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high tech ceramics

4 1 1 - 1 - 1 - 1 - PREMARKET NOTIFICATION - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 -

Device

Metoxit CAM-Blanks

## K072569

## 510 (k) Summary

007 ຊຶ່ງ 2007

| Submission<br>Correspondent: | Emergo Group, Inc.<br>1705 S. Capital of Texas Hwy<br>Suite 500<br>Austin, TX 78746 |
|---------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail]<br>Contact: Ian Gordon<br>Sr. Vice President |
| Submission Sponsor: | Metoxit AG<br>Emdwiesenstrasse 6<br>CH-8240 Thayngen |
| | Phone: [phone]<br>Email: [e-mail]<br>Contact: Dr. Wolfram Weber, General Manager |
| Date summary prepared: | July 31, 2007 |
| Device trade name: | Metoxit CAM-Blanks |
| Device common name: | CAM-Blanks |
| Device classification name: | Porcelain Powder for Clinical Use |
| Legally marketed devices<br>to which the device is<br>substantially equivalent: | K013230, K051462 - Cercon base<br>K051462 Cercon base colored<br>K050903 XAWEX G100<br>K022996 Vita YZ cubes<br>K051705 Ivoclar ZIRCAD<br>K052130 Vita AL cubes<br>K062506 Sirona InCoris AL<br>K001815 DCS DC-Zirkon |
| Description of the device: | Metoxit CAM-Blanks are dental ceramics, composed of yttrium-oxide<br>stabilized tetragonal zirconium-oxide polycrystals.<br>Metoxit CAM-Blanks are designed for the manufacturing of substructures<br>for all-ceramic dental appliances. The dental appliance is machined either<br>by CAD/CAM machining technique or the copying technique, then sintered<br>to full density and strength and for the sole use of the particular patients.<br>Metoxit CAM-Blanks are designed for the use as single tooth restorations<br>or bridgeworks with up to two pontics in the anterior as well as in the<br>posterior teeth region. |
| Intended use of the device: | Metoxit blanks are indicated for use as a substructure for porcelain fused<br>ceramic fixed dental restorations |
| | |
| Technological<br>characteristics: | The technological characteristics between the predicate and proposed<br>devices are identical. There is no difference in fundamental scientific<br>technology. They are made from the same materials and have the same<br>intended use. |
| Conclusions: | By definition, a device is substantially equivalent when the device has the<br>same intended use and the same technological characteristics as the<br>predicate device. |
| | There are no significant differences between the Metoxit CAM - Blanks<br>and the predicate devices and therefore, the Metoxit CAM-Blanks do not<br>raise any questions regarding safety and effectiveness. |
| | The Metoxit CAM-Blanks, as designed, are as safe and effective as the<br>predicate device, and the device is determined to be substantially<br>equivalent to the referenced predicate devices currently on the market. |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

2007

Metoxit AG C/O Mr. Ian Gordon Senior Vice President Emergo Group, Incorporated 1705 South Capital of Texas Highway Suite 500 Austin, Texas 78746

Re: K072569

Trade/Device Name: Metoxit CAM-Blanks Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: September 6, 2007 Received: September 12, 2007

Dear Mr. Gordon:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2- Mr. Gordon

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807,97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Nusf R.S. Ogle

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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**510(k) PREMARKET NOTIFICATION**

## Indications for Use State

510(k) Number:

- 1564

## Indications for Use:

Metoxit blanks are indicated for use as a substructure for porcelain fused ceramic fixed dental restorations. Limitations are listed in Table 1.

| | | | Table 1: Indications of use and maximum number of pontics. |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---|-------------------------------------------------------------------|------------------------------------------------------------|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | . | Comments of the program and the comments of lines and the bearing | |

| Process chain | Material | Single unit crowns | | Bridges, number of pontics | |
|--------------------------------------------------------------------------------------------|----------|--------------------|-----------|----------------------------|-----------|
| | | Anterior | Posterior | Anterior | Posterior |
| Porous blank is<br>machined to<br>enlarged<br>framework, then<br>sintered and<br>veneered. | TZP-A | X | X | 2 | 2 |
| | Al-999 | X | X | 1 | - |
| Dense blank is<br>machined to<br>net-shape<br>framework, then<br>veneered. | TZP | X | X | 2 | 2 |
| | TZP-A | X | X | 2 | 2 |

X indicated; - not indicated; digits show maximum number of pontics.

All blanks are solely by or on the order of a dental professional. They are not for use by the general public or over-the-counter.

Prescription Use AND/OR X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Suan Runse

on Sign-Off) ion of Anesthesiology, General Hospital, John Control, Dental De